PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

NCT04235439 | Completed Phase 1 FDA Drug

• 1 other identifier: GL - LSP - 1006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan \& Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male subjects Secondary objectives: To compare the PK and PD parameters of the three insulin lispro preparations To evaluate the single dose safety and local tolerability of the three insulin lispro preparations

Conditions

Diabetes Mellitus

Keywords

Diabetes; Insulin; Lispro; Diabetes Mellitus; Basal; Bolus

Outcome Measures

Primary Outcomes (4)

• AUCins.0-12h

  PK Endpoint: The area under the insulin concentration curve from 0 to 12 hours.

  0 to 12 hours

• Cins.max

  PK Endpoint: The maximum observed insulin concentration.

  0 to 12 hours

• AUCGIR.0-12h

  PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours.

  0 to 12 hours

• GIRmax

  PD endpoint: The maximum glucose infusion rate.

  0 to 12 hours

Secondary Outcomes (19)

• AUCins.0-2h

  0 to 2 hours

• AUCins.0-4h

  0 to 4 hours

• AUCins.0-6h

  0 to 6 hours

• AUCins.6-12h

  6 to 12 hours

• AUCins.0-∞

  0 to 12 hours

Study Arms (3)

Gan & Lee Insulin Lispro Injection

EXPERIMENTAL

Insulin lispro, 3 mL cartridge in prefilled pen, 100 units/mL (U-100)

Drug: Gan & Lee Insulin Lispro Injection

EU - approved Humalog ®

ACTIVE COMPARATOR

Insulin lispro (product approved and marketed in the EU), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)

Drug: Gan & Lee Insulin Lispro Injection

US - licensed Humalog ®

ACTIVE COMPARATOR

Insulin lispro (product approved and marketed in the US), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)

Drug: Gan & Lee Insulin Lispro Injection

Interventions

Gan & Lee Insulin Lispro Injection DRUG

All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.

Also known as: EU - approved Humalog ®, US - licensed Humalog ®

EU - approved Humalog ®; Gan & Lee Insulin Lispro Injection; US - licensed Humalog ®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated informed consent obtained before any trial related activities. Trial related activities are any procedures that would not have been done during normal management of the subject
• Healthy male subjects
• Age between 18 and 64 years, both inclusive
• Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2, both inclusive
• Fasting plasma glucose concentration \<= 5.5 mmol/L (100 mg/dL) at screening
• Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator

You may not qualify if:

• Known or suspected hypersensitivity to IMP(s) or related product
• Previous participation in this trial. Participation is defined as randomized
• Receipt of any medicinal product in clinical development within 30 days before randomization in this trial
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
• Any history or presence of clinically relevant comorbidity, as judged by the Investigator
• Signs of acute illness as judged by the Investigator
• Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator
• Clinically significant abnormal screening laboratory tests, as judged by the Investigator
• Elevation of serum ALT\> 10% above the ULN, or elevation of serum AST or serum bilirubin \>20% above the ULN. (Note: Elevation of bilirubin is considered acceptable in case of Gilbert's disease and should be evaluated in clinical context)
• Elevation of serum creatinine \> ULN, or elevation of serum urea \> 10% above ULN
• Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
• Symptoms of arterial hypotension
• Heart rate at rest outside the range of 50-90 beats per minute
• Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Profil Mainz GmbH & Co. KG

Mainz, 55116, Germany

Location

Related Publications (1)

• Chen W, Lu J, Plum-Morschel L, Andersen G, Zijlstra E, He A, Xie T, Li L, Hao C, Gan Z, Heise T. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin(R)), lispro (prandilin(R)) and glargine (basalin(R)) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023 Dec;25(12):3817-3825. doi: 10.1111/dom.15281. Epub 2023 Sep 21.

  PMID: 37735841 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

gallium nitrate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Jia Lu, PhD

  Gan & Lee Pharmaceuticals, USA

  STUDY DIRECTOR

• Leona Plum - Mörschel, Dr. med

  Profil Mainz GmbH & Co KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a phase 1 trial. The trial is a single center, randomized, doubleblind, single dose, there treatment, three period crossover, 12 - hour euglycaemic glucose clamp trial in healthy male subjects.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: April 23, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)